PharmaVOICE - 
June 2019
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In Every Issue
Letter from the Editor
Trending Now… As we head into the second half of [...]
By

Taren Grom, Editor

Upfront
Merck Debuts Documentary A Touch of Sugar Merck’s documentary film, [...]
By

PharmaVOICE Staff

Innovator’s Corner
Colon Cancer Screening without the Prep Alex Ovadia, CEO of [...]
By

Alex Ovadia, CEO of Check-Cap

HealthTech
A Mobile Game That Can Detect Alzheimer’s Risk Trend Watch: [...]
By

PharmaVOICE Staff

Artificial Intelligence
IBM to use ML and AI to Diagnose Alzheimer’s Trend [...]
By

PharmaVOICE Staff

Last Word
Anything But Generic Leadership Marc Kikuchi, the newly appointed CEO [...]
By

Marc Kikuchi, the newly appointed CEO of Dr. Reddy’s North America

On The Cover

The Realities of VR and AR in the Industry
Pharma brings complicated material to life with augmented and virtual reality. Imagine you are standing in your exhibit booth on a very crowded scientific and educational meeting floor, armed with fascinating, yet difficult-to-understand medical content that needs to make its way to the many passing physicians in order to educate them on the science your [...]
By

Robin Robinson

Features

SHOWCASE: Clinical Trial Solutions: Technology the Key to Improving Efficiencies and Retention in Clinical Trials
The use of technology has become ubiquitous in clinical trials as the industry looks to streamline and improve processes. Most pharmaceutical companies and contract research organizations have adopted technology solutions, including electronic data capture solutions and clinical trial management systems to increase efficiencies, reduce costs, and improve the patient experience. These solutions have been instrumental [...]
By

PharmaVOICE Staff

Addressing E6(R2) as an SMB: Why Small Pharma and Emerging Biotechs May be Falling Behind
It’s been three years since ICH added the E6 (R2) addendum to its Good Clinical Practice guidelines. The addendum was intended to create harmonization between US and EU clinical research regulations, and to drive adoption of quality risk management methodologies in clinical trial design, conduct, and oversight. To achieve compliance, sponsors must implement an end-to-end [...]
By

Cheryle Evans, Senior VP, Clinical and Medical Operations, Advanced Clinical

Data Ownership: Setting Up Your Study for Success
A small-to medium-size biotech or medical device company typically succeeds or fails on one pivotal study. It cannot be underestimated how important the study and operational data are to the success of that organization. The paramount consideration needs to be, do you have ownership of that data? Let’s talk about that now. Whether you are [...]
By

Andrew Schachter, CEO and Founder, Axiom Real-Time Metrics

Simplifying the Patient Experience Through Technology
Most businesses and individuals involved in clinical research would argue that an industry priority should be improving the patient experience. The reality, though, is often quite different. Patient focus potentially simplifies the research conducted today and accelerates potential future benefits of wearable devices, mobile apps and other services and technologies. Extending the simplicity and reach [...]
By

Mike Nolte,CEO ,CRF Bracket

The Vital Role of Imaging in Clinical Trials
Technology and innovation are reshaping clinical trials. Nowhere is this more evident than in the use of imaging in drug and device research. Over the last 10 years imaging has evolved from mostly qualitative assessments to more and more truly quantitative measurements. This is driven by the increasing need to visually demonstrate safety and efficacy [...]
By

Amit Vasanji, Ph.D. , Chief Technology Officer, Imaging, ERT Inc. and Brett A. Hoover
Director of Product Management, Imaging, ERT Inc.

Increasing Predictability in Patient Recruitment
Protocol Complexity and Optimization According to industry research1 there is increasing complexity in protocol design. This same research suggests that the demands on patients participating in trials are rising as a result of this and that there has been 70% increase in the total number of patient procedures in a typical Phase III trial. Assessing [...]
By

E.B. McLindon, Senior VP, Site and Patient Solutions, ICON Clinical Research Services

Virtual Trials Have (Finally) Arrived: How this remote model is transforming the clinical research experience, leading to lower costs and easier recruiting.
The pharma industry has been talking about the benefits of virtual trials for years, but it’s only recently that the promise of conducting complex efficacy studies in patients’ homes has finally become a reality. Industry leaders began singing the praises of virtual models around 2012, shortly after Pfizer conducted the first-ever randomized clinical study that [...]
By

Josh Rose, VP, R&DS Global Strategy and Head of Virtual Trial Solutions, IQVIA

The AI Revolution in Multivigilance
Advanced Technology Helps Protect Patients and Billions in R&D Investment. Bringing a new medicine, medical device, vaccine, or combination product to market today requires enormous investment. PhRMA estimates that a new drug takes nearly a decade to make it from discovery to approval and an overall investment of more than .6 billion. During that journey [...]
By

Bruce Palsulich, VP of Product Strategy, Oracle Health Sciences

Leveraging Patient-Centric Data Analytics to Accelerate Clinical Trials
We are all familiar with the figures — it takes over a decade and .6 billion to bring a new drug to market. While these objective statistics are daunting and do give pause, almost every life science professional will agree that they don’t begin to tell the true story of the human element below their [...]
By

Crystal Black, Director of Marketing Programs, Saama Technologies

Clinical Trial Solutions: Technology Disrupters
The biopharma industry faces myriad challenges in the pursuit of its mission to bring new treatments to patients in need of cures, chief among them the “Iron Triangle” of time, cost, and quality with respect to clinical research. The cost of conducting clinical trials is escalating, quality remains paramount and the importance of accelerating insights [...]
By

A.K. Gupta, Senior VP and Chief Information Officer, UBC

Marketing High Science Brands
The Challenge: Creating compelling campaigns for complex science Cancer immunotherapies and other high-science brands will be busting the market at billion by 2024, according to GlobalData. As the science around these types of treatments continue to drastically change therapeutic options, their commercial success will depend on the speed with which they enter the market, [...]
By

Robin Robinson

The Agile R&D Organization
A project management philosophy popular among technology companies has learnings for pharma R&D. Agile project management, first introduced in 2001, started out as a method used in software development that challenged the traditional, linear development model. The same benefits realized by the software industry, experts say, can be realized in pharmaceutical R&D. Agile takes a [...]
By

Denise Myshko

Charting Their Own Course
Every entrepreneur’s journey is as unique as he or she is. The common denominator:  a passion to improve the lives of patients. Risk-takers, disrupters, change agents, visionaries — more than a dozen industry entrepreneurs discuss what it takes to make the bold step to create something new and the twists and turns of their journeys. [...]
By

Taren Grom, Editor

Speak Out
Disruptive Innovation Drives Positive Outcomes Best Practices for Adopting the Shared Investigator Platform The Cognizant Shared Investigator Platform – SIP – is the disruptive innovation our industry sorely needs to reduce the burden placed on sites conducting clinical trials. Stakeholders from across the industry have expressed that sentiment to me countless times since I joined [...]
By

Larissa Comis, Product Leader, Shared Investigator Platform, Cognizant

Executive Perspective
Transforming the Lives of Patients: A Conversation with Ron Menezes When Ron Menezes, President and General Manager of Almirall, LLC, took the helm of the U.S. market for the global, Spanish-based company, his mission was clear: become a leader in innovation in the dermatology market. The company set out to refine its pipeline by focusing [...]
By

Ron Menezes, President and General Manager of Almirall, LLC

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